drugset / Trial / NCT00823316

Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation

NCT00823316 ↗

Phase 1/2 Completed 10 enrolled Medipost Co Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.

Timeline

Start
2008-08
Primary completion
2010-02
Completion
2010-02

Drugs

EvaluationDrugModalityDoseRoute
Subject human umbilical cord blood derived mesenchymal stem cells Cell therapy 1e+06 cells/kg Intravenous
Subject human umbilical cord blood derived mesenchymal stem cells Cell therapy 5e+06 cells/kg Intravenous

Indications